Diagnosis catheter for interstitial cystitis

ABSTRACT

A diagnosis catheter  1  for an interstitial cystitis is connected to a current perception threshold inspection apparatus  4 . A catheter body  11  is made of a soft flexible material and includes a bladder-dwelling distal end section A and a diagnosis section B adjacent the distal end section A at a proximal end side of the body  11 . A core member  12  is made of a hard flexible material and is inserted into the diagnosis section B in the catheter body  11 . An inflatable balloon  13  is mounted on an outer periphery around the bladder-dwelling distal end section A of the catheter body  11 . A fluid supply passage  16  is provided in the catheter body  11  so that an end of the passage  16  is communicated to the balloon  13  and a proximal end of the passage  16  is communicated to an injection part  17.

FIELD OF THE INVENTION

This invention relates to a diagnosis catheter for an interstitialcystitis and more particularly relates to a balloon catheter withelectrodes to be used for diagnosis of an interstitial cystitis.

BACKGROUND OF THE INVENTION

A balloon catheter with electrodes is well known and is generally usedfor diagnosis or treatment of a neurotic cystitis, an acraturesis, orthe like. However, there is no example in which the balloon catheterwith the electrodes has been used for diagnosis of the interstitialcystitis. Since a conventional balloon catheter with electrodes hasexposed hard electrodes, it is not suitable for insertion into a bladderthrough a urethra.

There is a current perception threshold (CPT) inspection apparatus thathas been recently developed to diagnose an abnormality of a peripheralnerve. This inspection apparatus evaluates an amount of a currentstimulation at the lowest level that a subject can feel when a feeblealternating current is supplied to a pair of electrodes stuck on a skinof the subject. The CPT inspection apparatus is generally utilized in ameasurement of a treatment effect (anesthesia), a measurement of anaffected portion (plastic surgery), an evaluation of a diabeticperipheral neuropathy (medicine), a quantitative evaluation of aperceptive nerve (neurology), a diagnosis for distinguishing a diseasebetween an impotence due to a neuropathy and a psychogenetic impotence(urology), an evaluation of an injury and a perception (dentistry), aquantitative measurement of a pharmacodynamics effect (pharmacology),and the like.

The above CPT inspection apparatus is also used in a urology to diagnosea urinary organ outside a body of the subject. However, the CPTinspection apparatus has not been used for diagnosis of the interstitialcystitis. The interstitial cystitis is a disease that has been foundrecently. A deterministic diagnosis has not been found yet, althoughthere are many subconscious patients.

The interstitial cystitis is often caused in women in the ages of 20 to60. The interstitial cystitis often appears as a symptom such as a painin an upper part of a pubic bone, a thamuria, an urge uresiesthesia, orthe like. In a typical mucosa observation, a canker-appears in line-likeshapes on a bladder mucosa. Even in a lighter symptom, a spot bleedingappears on a substantially wide area of the bladder mucosa. A generalinflammation is a phenomenon that occurs between the time when a tissueis injured and the time when the injured tissue heals. However, thetissue continues to heal in the interstitial cystitis.

Since pathology of the interstitial cystitis has not been resolved yet,a common reference of diagnosis has not been proposed. There are variouscommon methods for diagnosing the interstitial cystitis, such as anendoscopy using a bladder mirror, an observation of an interior in thebladder utilizing an inflation by means of a water pressure, a bladderbiopsy in which an inflammatory tissue is removed and inspected outsidea body of a subject, and the like. However, any one of the abovediagnosis methods is not convenient and precise.

SUMMARY OF THE INVENTION

An initial symptom of the interstitial cystitis is a hypersensitivity ina urethra bladder. There is a method for injecting a K Cl (potassiumchloride) into a bladder in one of conventional simple inspectionmethods. However, this method induces a pain in a subject and the paincontinues after injection of the K Cl. This method is not suitable for alow injury inspection method. The K Cl is a serious matter in the lowinjury inspection for the interstitial cystitis that can be moderated byfilling a C-fiber into the bladder.

An object of the present invention is to provide a diagnosis catheterfor an interstitial cystitis that can diagnose the interstitial cystitissimply and precisely and does not cause a pain in a subject.

A diagnosis catheter for an interstitial cystitis in accordance with thepresent invention is connected to a current perception thresholdinspection apparatus to diagnose an interstitial cystitis. The cathetercomprises: a catheter body made of a soft flexible material andincluding a bladder-dwelling distal end section and a diagnosis sectionadjacent the distal end section at a proximal end side of the body; acore member made of a hard flexible material and inserted into thediagnosis section in the catheter body; an inflatable balloon mounted onan outer periphery around the bladder-dwelling distal end section of thecatheter body; a pair of electrodes provided on an outer periphery ofthe diagnosis section; lead wires inserted into the core member so thatfirst ends of the lead wires are connected to the electrodes and secondends of the lead wires are drawn out of a proximal end of the catheterbody to be connected to the current perception threshold inspectionapparatus; and a fluid supply passage provided in the catheter body sothat an end of the passage is communicated to the balloon and a proximalend of the passage is communicated to an injection part.

The electrodes may be separated away from each other in a diametricaldirection of the catheter body or in an axial direction of the catheterbody. Otherwise, the electrodes may be ring-like electrodes that extendcontinuously in a peripheral direction of the catheter body andseparated away form each other in an axial direction of the body.

The balloon attached to the bladder-dwelling distal end section isretained in the bladder after being inflated and a current is suppliedto the pair of electrodes provided on the outer periphery of thecatheter body. The catheter is formed into a soft structure since a partof the catheter from the distal end to a portion supporting the balloonis inserted into the urethra. The other part of the catheter from aportion supporting the electrodes to the proximal end is formed into adual structure in order to prevent connecting portions between theelectrodes and the lead wires and the lead wires themselves from beingbroken and in order to positively insert the catheter into the bladder.A conventional stylet for a catheter cannot be used since the lead wirespass through a lumen in the core member.

Also, preferably, the electrodes to be used are made of a flexiblematerial that gives less stimulation to the mucosa.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic longitudinal sectional view of an embodiment of adiagnosis catheter for an interstitial cystitis in accordance with thepresent invention;

FIG. 2 is a cross sectional view of the catheter taken along line II-IIin FIG. 1;

FIG. 3 is a cross sectional view of the catheter taken along lineIII-III in FIG. 1;

FIG. 4 is a cross sectional view of the catheter taken along line IV-IVin FIG. 1;

FIGS. 5(A) to 5(C) are partial plan views of a portion of the catheterin accordance with the present invention, illustrating variousmodifications of electrodes of the catheter;

FIG. 6 is an explanatory view of an example in which the catheter of thepresent invention is used for diagnosis of an interstitial cystitis; and

FIGS. 7(A) and 7(B) are graphs illustrating a diagnosis result of eachinterstitial cystitis indicated on a display of a current perceptionthreshold inspection apparatus, FIG. 7(A) illustrating a normal value,and FIG. 7(B) illustrating an abnormal value.

PREFERRED EMBODIMENTS OF THE INVENTION

Referring now to FIGS. 1 to 5, an embodiment of a diagnosis catheter 1for an interstitial cystitis in accordance with the present inventionwill be described below. As shown in FIG. 1, the diagnosis catheter 1for the interstitial cystitis in accordance with the present inventionis connected to a current perception threshold inspection apparatus 4(CPT inspection apparatus) shown in FIG. 6 and is used to diagnose theinterstitial cystitis.

The diagnosis catheter 1 for the interstitial cystitis in accordancewith the present invention includes mainly a catheter body 11, a coremember 12, an inflatable balloon 13, a pair of electrodes 14, lead wires15, and a fluid supply passage 16.

The catheter body 11 is made of a soft flexible material (for example,silicone rubber) and includes a bladder-dwelling distal end section Aand a diagnosis section B adjacent the distal end section A at aproximal end side of the body 11. The core member 12 is made of a hardflexible material (for example, TEFLON (trade name)) and is insertedinto the diagnosis section B in the catheter body 11. The inflatableballoon 13 is mounted on an outer periphery around the bladder-dwellingdistal end section A of the catheter body 11.

The pair of electrodes 14 are provided on an outer periphery of thediagnosis section B. The lead wires 15 are inserted into the core member12 so that first ends of the lead wires 15 are connected to theelectrodes 14 and second ends of the lead wires 15 are drawn out of aproximal end of the catheter body 11 to be connected to the currentperception threshold inspection apparatus 4.

The fluid supply passage 16 is provided in the catheter body 11 so thatan end of the passage 16 is communicated to the balloon 13 and aproximal end of the passage 16 is communicated to an injection part 17.A fluid (for example, air, water, or the like) is supplied through theinjection part 17 to the balloon 13 to inflate the balloon 13.

The electrodes 14, as shown in FIG. 5, may be separated away from eachother in a diametrical direction of the catheter body (FIG. 5(A)) or inan axial direction of the catheter body (FIG. 5(B)). Otherwise, theelectrodes 14 may be ring-like electrodes that extend continuously in aperipheral direction of the catheter body 11 and separated away formeach other in an axial direction of the body 11 (FIG. 5(C)).

EXAMPLE

Referring to FIGS. 6 and 7, an example of diagnosis of the interstitialcystitis utilizing the catheter 1 of the present invention will beexplained below.

As shown in FIG. 6, the catheter 1 is inserted into a bladder 2 in apatient. The balloon 13 of the catheter 1 is inflated to retain thebladder-dwelling distal end section A of the catheter body 11. At thistime, the diagnosis section B of the catheter body 11 is disposed on anaffected area near an inlet port of the bladder 2. The lead wires 15extending from the proximal end of the catheter 1 are connected to aninput terminal 41 of the current perception threshold inspectionapparatus 4. A power source 43 and a display 42 are connected to theapparatus 4.

A feeble alternating current with a given frequency (5 to 2000 Hz) issupplied from the current perception threshold inspection apparatus 4 tothe lead wires 15 of the catheter 1. The current flows through theelectrodes 14 into the affected area in the bladder 2. The display 42indicates a current level at the time when the patient feels the currentflow. FIG. 7 shows an example of an indicating result of the currentflow feeling-level. FIG. 7(A) shows a normal value while FIG. 7(B) showsan abnormal value.

POSSIBILITY OF UTILIZATION IN AN INDUSTRIAL FIELD

According to the present invention, it is possible to simply andprecisely diagnose an interstitial cystitis by using a catheter having asimple and inexpensive structure. The catheter does not cause a pain ina subject during inspection. The catheter of the present invention willbe useful for a diagnosis of an irritable bowel syndrome.

1. A diagnosis catheter for an interstitial cystitis wherein a catheteris connected to a current perception threshold inspection apparatus todiagnose an interstitial cystitis, wherein the current perceptionthreshold inspection apparatus indicates a current level at the timewhen a patient feels the current flow, the diagnosis cathetercomprising: a catheter body made of a soft flexible material andincluding a bladder-dwelling distal end section and a diagnosis sectionadjacent said distal end section at a proximal end side of said body; acore member made of a hard flexible material and inserted into saiddiagnosis section in said catheter body; an inflatable balloon mountedon an outer periphery around said bladder-dwelling distal end section ofsaid catheter body; a pair of electrodes provided on an outer peripheryof said diagnosis section, wherein the electrodes supply electriccurrent flow at a level such that it can be felt by the patient; leadwires inserted into said core member so that first ends of said leadwires are connected to said electrodes and second ends of said leadwires are drawn out of a proximal end of said catheter body to beconnected to said current perception threshold inspection apparatus; anda fluid supply passage provided in said catheter body so that an end ofsaid passage is communicated to said balloon and a proximal end of saidpassage is communicated to an injection part.
 2. A diagnosis catheterfor an interstitial cystitis according to claim 1, wherein saidelectrodes are separated away from each other in a diametrical directionof said catheter body.
 3. A diagnosis catheter for an interstitialcystitis according to claim 1, wherein said electrodes are separatedaway from each other in an axial direction of said catheter body.
 4. Adiagnosis catheter for an interstitial cystitis according to claim 1,wherein said electrodes are ring-like electrodes that extendcontinuously in a peripheral direction of said catheter body andseparated away form each other in an axial direction of said body.
 5. Adiagnosis system comprising: a diagnosis catheter comprising: a catheterbody made of a soft flexible material and including a bladder-dwellingdistal end section and a diagnosis section adjacent said distal endsection at a proximal end side of said body; a core member made of ahard flexible material and inserted into said diagnosis section in saidcatheter body; an inflatable balloon mounted on an outer peripheryaround said bladder-dwelling distal end section of said catheter body; apair of electrodes provided on an outer periphery of said diagnosissection, wherein the electrodes supply electric current flow at a levelthat can be felt by a patient; lead wires inserted into said core memberso that first ends of said lead wires are connected to said electrodesand second ends of said lead wires are drawn out of a proximal end ofsaid catheter body to be connected to said current perception thresholdinspection apparatus, wherein the current perception thresholdinspection apparatus indicates a current level at the time when thepatient feels the current flow; and a fluid supply passage provided insaid catheter body so that an end of said passage is communicated tosaid balloon and a proximal end of said passage is communicated to aninjection part, wherein said current perception threshold inspectionapparatus connected to said diagnosis catheter; a display connected tosaid current perception threshold inspection apparatus; and a powersource connected to said current perception threshold inspectionapparatus.
 6. A diagnosis system as recited in claim 5, wherein: saidelectrodes are separated away from each other in a diametrical directionof said catheter body, and said current perception threshold inspectionapparatus is connected to said diagnosis catheter; said system furthercomprising: a display connected to said current perception thresholdinspection apparatus; and a power source connected to said currentperception threshold inspection apparatus.